July 11, 2018 Read Original Release

Announcement tempts people suffering disabling hand condition with ‘new hope’ based on study of surrogate markers

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Rating

New hope for patients with incurable and disabling hand condition, Dupuytren's disease

Our Review Summary

The headline of this news release promises “new hope” for patients with Depuytren’s disease: a disabling hand condition characterized by progressive contracting of the fingers into a clawlike deformity. The cause is unknown, the course of the disease is often gradually progressive, and there’s no curative treatment.

The study highlighted in the release only shows chemical changes over two weeks in 28 subjects. It can’t show (or promise) clinical improvements in patients’ hand deformities.

The key question for patients is: “will this therapy decrease the frequency or severity of the disabling finger contractures?” The news release doesn’t make it clear enough that the study looked at the level of genetic markers associated with myofibroblasts and that these markers (called “surrogate markers“) may not even affect how the disease progresses clinically.

The news release also falls short in discussing costs, potential harms, alternative nonsurgical treatments, and significant financial conflicts of interest among most of the study authors.

For the lead authors — who stand to benefit from patents related to this therapy — to dangle “new hope” at this very preliminary stage of laboratory research is premature and arguably irresponsible.

Why This Matters

Depuytren’s disease can be very disabling and very difficult to treat. Progressive cases are mostly managed by chemical or surgical attempts to break tightening knots or cords of abnormal tissue that pull the fingers into a clawlike deformity. Even with treatment recurrence is common.

The premise of this therapy is that injecting the hands of patients with an anti-TNF drug (Humira) may decrease the proliferation of two cell types (fibroblasts and myofibroblasts) and, in turn, improve the disease.

An early treatment, before Depuyten advances, would not only be a boon to patients, but a financial boon to developers (like the lead authors of this study).

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The cost of a single 40 mg injection of the the anti-TNF (tumor necrosis factor) drug, adalimumab (brand name, Humira) isn’t mentioned. Given the level of the research at the moment, the durability of what can best be described as a change in a surrogate marker is unknown. Although the cost of 40mg of Humira is around $5,000 for two 40mg/0.8ml pens, according to GoodRx, the true cost of this potential treatment is unknown but likely to be costly.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

According to the release, a single injection of Humira “results in the reduction of the cell characteristics responsible for progression of Depuytren’s disease.”

This is vague, misleading, and inaccurate because what causes progression in this disabling hand disease is unknown, and most certainly can not be definitively attributed to “cell characteristics.”

The study was designed to better understand the impact of adalimumab on local level of several disease markers namely myofibroblast phenotype and collagen production in excised nodule samples and not necessarily on disease progression. The results were far from as conclusive as the report would suggest with only one marker demonstrating a difference over placebo at the highest dose level.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

It’s mentioned the researchers “found the drug to be safe and well tolerated.” The associated research paper mentions “there were two serious adverse advents, both considered unrelated to the study drug.” But no further information is provided. The release could have been more informative regarding potential harms from the drug.

Humira has been documented to cause a host of side-effects. It carries a black box warning for compromising immunity, and has been reported to make people more prone to tuberculosis and skin cancer.

Of note, these side effects were noted in patients given subcutaneous Humira. The Humira in this study was administered locally in the hand, which could be less likely to cause systemic side effects.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release does not make it clear enough that this study relies on changes in surrogate markers after injection in a very small number (n=28) of subjects.

Whether this laboratory finding will translate into meaningful clinical outcomes for patients — such as decreasing the frequency or severity of subsequent muscle tightening and shortening — is not addressed, and is what would matter most to patients with this disease.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering here. It’s mentioned Depuytren’s disease affects about 4% of the population.

(This percentage is much higher in parts of Northern Europe.)

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

This is a major weakness of the news release.

Although sources of funding are included (Wellcome Trust, Department of Health, 180Therapeutics.com) in the release, it’s not made clear that the two co-authors quoted have patents with 180Therapeutics related to this therapy.

In fact, the majority of the 17 authors listed on this study have financial ties to 180Therapeutics, a for-profit company focused solely on anti-TNF therapeutics (which the website mentions is a “$30-billion annual drug market class”).

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Surgery is the only other therapy mentioned in this news release.

It does not mention two other common treatments: needling and enzyme injections (physical and chemical attempts to break up contractures, respectively).

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s noted that this treatment approach is in phase IIa trial; that is, preliminary evaluation of short-term safety and efficacy.

However, the language used in the release: “The team found that adalimumab (at a dose of 40mg formulated in 0.4ml) reduces expression of the fibrotic markers, -smooth muscle actin (-SMA) and type I procollagen, at 2 weeks post injection” suggests this drug (which is commercially available for other conditions) could be used to stop the growth of disease causing myofibroblast cells. A simple statement in the release noting the preliminary nature of the research would have gone a long way into placing the the drug’s availability into proper perspective.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The novelty of this treatment approach is not addressed in the news release. However, according to the published study, this research group appears to have been instrumental in exploring the role of TNF in this condition.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

Highlighting “new hope” in the headline, and claiming “the results so far are very promising,” are unjustified given this is a small, preliminary study showing changes in surrogate markers only two weeks after treatment in 28 subjects.

Total Score: 2 of 10 Satisfactory

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